Amy Ng Email & Phone Number

Canada

Forchheim, De

Overseeing work related to verification and validation activities of both new and on-market product to support regulatory applications and post-market documentation.Managing and performing data acquisition for various in-house and field verification and validation studies such as but not limited to Alpha Studies, Clinical Trials, Method Comparison, Precision, Limit of Quantification, Interference Testing, and Field Performance Evaluations.Engages with various stakeholders involved in collaboration activities including but not limited to Regulatory Affairs, Clinical Affairs, Marketing, Product Health, Research and Development, and Stability, Verification and Validation.Contributes to clinical trial study development and start-up process including developing protocols, drafting of IRB packages, consent forms, writing collaboration contracts, intercompany agreements, and volunteer Informed Consent forms. Manages the aspects of planification planning and execution of internal validation, preliminary evaluation studies, improvement activities, product portfolio life cycle management, and post-market evaluations, which may involve protocol development/study design, document management, and tracking of projects expenses and budget. Negotiates and finalize contracts for execution with support from legal, regulatory and compliance. Participates in on-site visits, executes alpha studies, supports, and trains clinical sites on implementing and conducting study protocols. Assists in the development of collateral, or other customer facing deliverables, such as but not limited to case studies, proof points, white papers, or customer bulletins in close collaboration with R&D, Quality, Regulatory and Marketing as required. Assists with preparation of regulatory submissions such as but not limited to FDA Pre-Submission, FDA 510(k) Submission, IVDR Submission, and CLIA Waiver, as required.

Forchheim, De

• Responsible for the management of the Product Eng. Clinical lab team with emphasis on quality data, timelines, budget, teamwork and compliance with SOP’s GMP’s and PWIs. • Developed, executed, and maintained company SOP’s, SWI’s, GMP regulations, Quality Programs, Client/ Internal and Government Audits to maintain compliance. • Responsible for all study related, clinical related documents are tracked, filed and reviewed and complete in accordance to SOPs, protocols and regulatory requirements. • Conduct and oversee plans, strategies, tools and training for clinical lab team.• Management of the lab budget to ensure projects are met within budget and scope of work.• Responsible and accountable for investigation and report writing of CAPA’s, IR’s and use of risk identification and mitigation tools. • Manage and coordinate third party proficiency testing to ensure lab is operating to standardized performance for field performance. • Investigated and reported customer complaints with detailed communication to internal and external upper management.

Forchheim, De

• Ensures that the relevant principles and ceremonies are understood and adhered to by the team (e.g. sprint planning, standups, sprint demo, retrospective, backlog refinement).• Guides the team along all relevant PLM process steps and ensures that the team deliverables are in quality and compliant to the defined process framework.• Supports and coaches the team to keep focus and achieve transparency in its progress also towards external stakeholders (e.g. project managers, product owners).• Supports and coaches the team to commit to challenging but realistic and reliable sprint results• Supports and coaches the team in removing or escalating impediments that the team cannot solve internally.• Takes care for a timely and constructive cooperation of the team with the product owner or other stakeholders.• Fosters reflection and continuous learning to increase team performance and value orientation.• Facilitates the team's creativity and self-empowerment to challenge product content definition and way of working.• Exchange best practices and collaborating with other scrum teams.• In case of large project supports inter team synchronization (e.g. scrum of scrums).

Forchheim, De

Epocal is a biotechnology company that develops medical technology for point of care blood analysis systems. Involved in testing of :Customer complaints investigations for product improvement Software Configurations and release of new softwareValue Assignments for sensor configuration, incoming QC fluids and field QC fluids Linearity Testing where each analyte is assessed by checking the performance of recovery throughout the manufacturer’s stated range of the testing systemProficiency Testing for evaluated lab grading and performance: API, CAP, WEQAS and WSLH- Coordination of lab personnel and scheduling of all testing required of department- Assistance with testing for R&D experiments- Inventory of Lab supplies and ordering of supplies at appropriate reorder points- Conducts monthly lab inventory and consumption rates- Organize lab to optimize efficiency of the lab using LEAN processes - Carry out routine maintenance and basic troubleshooting of lab testing equipment, and record these activities in maintenance logs

Forchheim, De

Epocal is a biotechnology company that develops medical technology for point of care blood analysis systems. - Finished Goods testing of cards & readers for release of EPOC cards on tight deadlines- Reader Validations testing and report generation- Routine performance checks ; Adaptive Process Control, linearity’s, lifetimes, and validations- Adaptive Process Control tests done on product to determine and adjust manufacturing and production of EPOC cards- Assistance with testing for Process Engineering, Test Engineering and R&D experiments- Inventory of clinical lab supplies and ordering of supplies at appropriate reorder points- Conducts monthly lab inventory and consumption rates- Organize lab to optimize efficiency of the lab using LEAN processes - Carry out routine maintenance and basic troubleshooting of clinical lab testing equipment, and record these activities in maintenance logs

- Managing dance crew schedules - Keeping track of attendance and absences - Music mixing preperation for shows- Prepare dancers for competitions and paid performances- Lead and direct dance troupe - Artistic development - Planning for group travels and performances

Dance organization dedicated to innovative performance, artistic development and community enrichment.

Seattle, Wa, Us

As a pharmacy assistant my daily responsibilities include working together with patients, physicians and other health care professionals to deliver quality customer service and medical knowledge on a variety of prescriptions. I am responsible for the input of prescriptions, filling of medications, communicating with doctors, patients, third party insurance companies and pharmacies in order to assist client needs in the most proficient manor. I personally strive to develop a rapport with all clients and medical professionals that I deal with on a daily basis. I communicate daily with drug disruption and sales companies and have received training in the use of glucose meters and other types of diabetes medications. Working within the pharmacy has allowed me to obtain knowledge of the profession and all of the interrelating services, including sales and marketing companies. I am proficient with the use of the Kroll database systems as well as communications with third party adjudicators and all allied medical professionals. - Ensure the right prescriptions are delivered to the customer using KROLL- Enter, filled and packed prescriptions efficiently- Perform pharmacy inventory counts- Answer customers' questions regarding procedures, products, and prices- Compound mixtures and suspensions with precision- Communicate with patients and doctors over the phone and through fax- Restock and reface shelves- Ordered OTC items for Pharmacy on a weekly basis

Ca

Lab focus was interested in using genetic and molecular approaches in C. elegans to study nervous system development. The area of interest hopes to gain new insight into the establishment and maintenance of neuronal polarity, neuronal migration and axon guidance.Human behaviour depends on the coordinated development of billions of neurons into functional circuits and networks. This complexity is attained by the intrinsic properties and shapes of neurons and their remarkable ability to find and make successful connections with each other and their target cells. The lab uses genetic and molecular approaches in the nematode C. elegans (Fig. 1) to study neuronal migration, axon guidance, and the underlying mechanisms that allow neurons to acquire and maintain characteristics such as polarized cell shapes and branched morphologies that distinguish them from other cell types. Understanding these processes may ultimately lead to the development of new drug targets or therapies that promote neuronal repair following brain injury or neurodegenerative disease.Research Paper: Using SNP-SNP genetic mapping as a tool in mapping mutations in the PCP pathway of C.ElegansAbstractThe planar cell polarity (PCP) pathway is a non-canonical Wnt-Frizzled pathway which is critical in several developmental role, one of which is regulation of neuronal development. In Caenorhabditis elegans the DD motor neurons are evenly spaced throughout the worm, however research from previous work in our lab has found that mutations in PCP components vang-1 (Van Gogh) and Prkl-1(Prickle) causes positioning defects in DD neurons. Using single nucleotide polymorphism (SNP) mapping, a simple yet very effective tool, we were able to narrow down the regions of interest on a gene to a physical location that can be used in further research.

Ca

Main surgical interests focus on all types of spine and spinal cord diseases such as spinal cord injury, spinal cord and spine tumors, syringomyelia, and myelopathy. Research was focused on spinal cord repair strategies, axonal regeneration, MRI imaging of spinal cord tracts in humans and animals, and clinical outcomes after spine surgery.- used MRIs extensively to examine patients- several sedation techniques were used during surgeries- sutured animals that had undergone experimental surgery- extensive research on channels that were used in the spinal cord- logged observations on subjects every 2 hours and made database of performance pre operative and post surgery

Ottawa, Ontario, Ca

Research in the lab examines alteration of protein structure and function by oxygen. In particular, the lack of such alteration under low oxygen (or hypoxic) conditions. Such conditions are commonly encountered by humans at high altitudes, during development, and in clinical conditions such as sleep apnea, hypertension, ischemic (or the cutting off of blood flow) heart disease, acute myocardial infarction, cardiac arrest, cerebrovascular disease (such as stroke), and neurocognitive deficits. Systemic or localized hypoxia affects metabolic pathways, induces angiogenesis (or the formation of new blood vessels), and affects inflammatory responses. Many of the factors that are involved in hypoxia survival are also found to be upregulated in most human tumors. As well as disease, ischemia-associated hypoxia plays a role in tissue damage during organ transplantation as well as preservation. Using mammalian cell lines (human, monkey, rat, etc.) as the model system and a proteomic approach, we examine changes in protein expression, function and stability under varying oxygen conditions.- run and analyze DNA electrophoresis gels- run and analyze RNA electrophoresis gels- make a database of all the chemical inventory in the lab- update the MSDS binders to ensure all safety sheets are current

Graduate Certificate, Clinical Trials Management

Project Management Professional

Bachelor’S Degree, Neuroscience